The government of Ireland has approved a four-year framework agreement on the supply and pricing of medicines, which is set to benefit the off-patent drug sector.
According to Medicines for Ireland, one of the agreed measures will encourage earlier launches of generics and biosimilars, ensuring timely access to cheaper medicines through tiered pricing and improved reimbursement processes.
The agreement also endorsed an earlier adoption of best-value biologics and the introduction of value-added medicines where they bring meaningful benefit, which, in return, will support Ireland’s financial sustainability.
Other measures included strengthening the security of supply, as well as promoting greater competition and market resilience.
The trade group’s chair Paul Neill said these measures were “precisely the typesof system improvements MFI has championed for years,” adding that the reforms will reduce the risk of shortages, enhance predictability, and help reinvest savings back into the healthcare system.
“This agreement in principle acknowledges the vital role that our sector plays in drivingvalue, diversity of supply, and long-term sustainability,” Neill commented, adding that the proposal will be finalized in the upcoming weeks.
The agreement will also benefit the innovative medicine industry as it will speed up the process of reimbursing new drugs in compliance with the law.
Critical Medicines Act Progresses But Industry Cautions
The European Parliament has voted in favor of the Critical Medicines Act in a recent plenary vote session, with 503 members of parliament supporting the proposal, 57 against, and 108 abstentions.
Medicines for Europe said the vote marked a “significant milestone” to ensure the region’s open strategic autonomy and address the economic root causes of drug shortages.
“We applaud the progressive position to advance Europe’s health security with this important vote. We are ready to work with the co-legislators to deliver a meaningful act that will enable the off-patent medicines sector to be competitive, especially in today’s unpredictable geopolitical landscape,” said the trade group’s director general Adrian van den Hoven.
However, there is still a significant risk that the CMA will be undermined by other outside frameworks, such as the heavily criticized Urban Wastewater Treatment Directive and its extended producer responsibility mechanisms.
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